OPTIMESH

Additional Manufacturer Narrative

THE CAUSE OF THE ADVERSE EVENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THE INFORMATION CONTAINED IN THIS REPORT IS BEING PROVIDED TO FDA TO COMPLY WITH MEDICAL DEVICE REPORTING REGULATIONS AND IS BASED ON INFORMATION SUBMITTED BY OTHERS THAT MAY NOT BE FACTUALLY CORRECT. THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OR ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR THAT A DEVICE IS RELATED TO AN INJURY OR DEATH.

Description of Event or Problem

AS REPORTED BY THE SURGEON: THE PATIENT UNDERWENT AN L5-S1 INTERBODY FUSION WITH PLACEMENT OF AN OPTIMESH DEVICE WITH BONE GRAFT IN A VERY COLLAPSED DISC SPACE WITHOUT INCIDENT ON (B)(6) 2019. THE PATIENT AWOKE WITH PRIOR SYMPTOMS RESOLVED BUT COMPLAINED OF NEW STIFFNESS IN RIGHT LEG WITH PAIN AND NUMBNESS IN RIGHT FOOT. THESE SYMPTOMS PERSISTED AND A CT SCAN ON (B)(6) 2019 SHOWED GOOD RESTORATION OF DISC HEIGHT AND FILLING OF THE OPTIMESH DEVICE BUT ALSO ALLOGRAFT BONE IN THE CENTRAL CANAL AND RIGHT NEURO-FORAMEN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 AND THE BONE IN THE CANAL WAS REMOVED. SYMPTOMS REMAINED PERSISTENT AND A NEW CT SCAN DURING THE WEEK OF (B)(6) 2019 STILL SHOWED BONE IN THE RIGHT NEURO-FORAMEN. THE SURGEON RECOMMENDED A NERVE ROOT INJECTION AND, IF SYMPTOMS PERSIST, A SECOND REVISION SURGERY TO REMOVE THE REMAINING BONE. THE LAST AVAILABLE PATIENT STATUS UPDATE INDICATES THAT A SECOND OPINION WAS SOUGHT.